PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40-80
SponsorBrigham and Women's Hospital
About this trial
PRECIDENTD is a randomized, open label, pragmatic clinical trial designed to compare rates of the total number of cardiovascular, kidney, and death events among two alternative treatments for patients with type 2 diabetes (T2D) and either established atherosclerotic cardiovascular disease (ASCVD) or at high risk for ASCVD. To accomplish this objective, we will randomly assign 6,000 patients with established T2D and ASCVD or high-risk for ASCVD in a 1:1 allocation to sodium-glucose cotransporter-2 inhibitor (SGLT2i) or glucagon-like peptide-1 receptor agonists (GLP-1RA). Participants will be followed for the occurrence of the trial primary endpoint of the total (first and recurrent) number of episodes of myocardial infarction (MI), stroke, arterial revascularization, hospitalization for heart failure, development of end-stage kidney disease, kidney transplantation, and mortality, counting all events from randomization until end of study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Type 2 diabetes based on clinical diagnosis
HbA1c ≥6% measured within 12 months prior to screening
Age 40 to 80 years
Evidence of established atherosclerotic cardiovascular disease (ASCVD), as defined by one or more of the following
Disqualifiers
Known or suspected diabetes of other cause (type 1 diabetes, pancreatogenic diabetes, monogenic diabetes, etc.)
History of diabetic ketoacidosis
Active diabetic foot ulcer
History of pancreatitis
Trial design
Design model
Parallel
Treatments tested in this trial
SGLT2 inhibitor
DrugEmpagliflozin, dapagliflozin, or canagliflozin
GLP-1 receptor agonist
DrugDulaglutide, liraglutide, semaglutide
Treatment groups
6,000 Participants
are divided into 2 treatment groupsGroup A: Sodium-glucose cotransporter-2 inhibitor (SGLT2i)Active comparator 1 intervention
Group B: Glucagon-like peptide-1 receptor agonist (GLP-1 RA)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Total (first and recurrent) cardiovascular, kidney, and death events
total (first and recurrent) number of episodes of myocardial infarction (MI), stroke, arterial revascularization, hospitalization for heart failure, development of end-stage kidney disease, kidney transplantation, and mortality
Time frame
Through study completion, with an average follow up of approximately 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Brigham and Women's Hospital
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Source ClinicalTrials.gov